MAUDE Adverse Event Report: ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA) SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TF-19A

Device Problems Backflow (1064); Material Perforation (2205); Infusion or Flow Problem (2964); Material Split, Cut or Torn (4008)

Patient Problems Congestive Heart Failure (1783); Dyspnea (1816); Insufficiency, Valvular (1926); Regurgitation (2259)

Event Date 12/20/2019

Event Type  Injury  

Event Description

On (b)(6) 2014, atrial valve replacement(avr) was performed along with pulmonary vein isolation(pvi) and left atrial appendectomy due to severe aortic stenosis(as) and paroxysmal atrial fibrillation (paf).Because of severe calcification on the annulus and narrow valsalva sinus, a 21mm valve could not be used; a 19mm sjm trifecta valve was implanted in supra-annular position with 12 stitches using non-everting mattress suture technique with pledgets.An abbott sizer (tf2000) was used in the surgery.There was no atrial regurgitation(ar) observed on the patient after the surgery for four years.However, mild ar was observed on the fifth year in (b)(6) 2019.The patient experienced shortness of breath during her trip on (b)(6) 2019, and was hospitalized due to heart failure.The patient was treated with medication and was discharged from the hospital once.However, moderate ar and mild mitral regurgitation(mr) were observed, and the patient was hospitalized again two weeks later.Right coronary cusp(rcc) movement could not be confirmed on echocardiogram.A re-do avr was performed on (b)(6) 2019.Upon explant, it was observed that the cusp was not fused to the aorta.A hole was confirmed on the stent post part between the rcc and the ncc with the top part still connected; the hole was thought to be due to either a tear or a perforation.Leaflets were found inside the stent posts with the rcc prolapsed inside.The patient was stable.No patient consequences were reported.

Manufacturer Narrative

The hole seen at explant was confirmed.All three leaflets were torn.The tear in leaflets 2 and 3 at stent post 3 as well as in leaflets 1 and 2 at stent post 2 resulted in a hole, the commissure of the two leaflets remained intact even though the leaflets were torn away from the stent post.Information from the field indicated that the leaflets were damaged at explant, so the extend of the damage prior to explant could not be conclusively determined.There were degenerative changes to the collagen fibers of all three leaflets, and all three leaflets contained fibrous thickening.No acute inflammation or significant calcifications were present.The stent posts were noted to be damaged as explant, as was the cuff.The device history record was reviewed to ensure each manufacturing and inspection operation was performed and the product met all specifications.In the absence of any calcification or evidence for infection, the reported event is consistent with a non-calcific leaflet tear.A non-calcific leaflet tear is a form of structural valve deterioration (svd), which is a well-known complication from valve replacement surgery.A non-calcific leaflet tear is commonly attributed to increased operational leaflet stress but may also be related to biological factors which result in tissue degeneration characterized by loss of collagen.In this case, histological evaluation demonstrated degenerative changes to the collagen of all three leaflets and at the tear sites, which could have contributed to the leaflet tear.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 9602431
• MDR Text Key: 176061082
• Report Number: 3001883144-2020-00004
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052016
• UDI-Public: 05414734052016
• Combination Product (y/n): N
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2016
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Device Lot Number: 4623991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 60